Over­sight from FDA at phar­ma man­u­fac­tur­ing sites dipped dur­ing 2021 pan­dem­ic

The FDA com­plet­ed less than half (48%) of its reg­u­la­to­ry ac­tions for phar­ma fa­cil­i­ties des­ig­nat­ed as OAI or with an Of­fi­cial Ac­tion In­di­cat­ed, with­in 6 months of an in­spec­tion clos­ing, ac­cord­ing to the lat­est re­port from the agency on the ef­fects Covid-19 had on gen­er­al over­sight at man­u­fac­tur­ing sites last year.

The agency al­so lost pace in is­su­ing fi­nal fa­cil­i­ty clas­si­fi­ca­tion let­ters.

In FY 2021, the re­port not­ed FDA is­sued 70% of fi­nal fa­cil­i­ty clas­si­fi­ca­tion let­ters with­in 90 days of in­spec­tion clos­ing. By com­par­i­son, in FY 2019, 87% of fi­nal fa­cil­i­ty clas­si­fi­ca­tion let­ters were is­sued with­in 90 days of in­spec­tion clos­ing, and com­plet­ed 74% of reg­u­la­to­ry ac­tions for OAI fa­cil­i­ties.

Pan­dem­ic mit­i­ga­tion ef­forts such as trav­el re­stric­tions have im­pact­ed the num­ber of in­spec­tions con­duct­ed by the FDA as re­sources were be­ing di­vert­ed to the pan­dem­ic re­sponse.

The back­log at the FDA has been well doc­u­ment­ed. In 2021, the Gov­ern­ment Ac­count­abil­i­ty Of­fice de­tailed that the FDA did not con­duct any new in-per­son in­spec­tions of Covid-19 vac­cine man­u­fac­tur­ing plants be­fore is­su­ing the EUAs for Pfiz­er, Mod­er­na and J&J’s shots. Mean­while, the agency in­stead had to re­ly on his­tor­i­cal find­ings for the 18 man­u­fac­tur­ing sites.

While the FDA is­sued mea­sures on con­duct­ing vir­tu­al eval­u­a­tions to get a han­dle on the back­log, there were still ma­jor lim­i­ta­tions to the re­mote pro­gram, and it on­ly filled a frac­tion of the in­spec­tions in the agency’s back­log.

The num­bers for 2022 will most like­ly not im­prove too much as even ear­li­er this year, the FDA qui­et­ly an­nounced it once again paused all its non-mis­sion-crit­i­cal in­spec­tions in the US, but those in­spec­tions have since re­turned to nor­mal.

Al­though more in­spec­tions, Form 483s, and warn­ing let­ters are start­ing to roll out again, the agency has a lot of catch­ing up to do if it wants to re­turn to pre-pan­dem­ic lev­els.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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Emer Cooke, ICRMA chair (AP Photo/Geert Vanden Wijngaert)

ICM­RA to launch sev­er­al reg­u­la­to­ry pi­lot pro­grams cen­tered around man­u­fac­tur­ing in­spec­tions

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

FDA slaps warn­ing let­ter on Min­neso­ta API fa­cil­i­ty af­ter em­ploy­ee de­stroys clean­ing log

A manufacturing facility belonging to the Netherlands-based API producer Fagron Group has entered the FDA’s crosshairs after an employee destroyed a cleaning log, among other violations.

One of its plants in Saint Paul, MN received a warning letter on June 14, following an inspection last November that uncovered cross-contamination concerns.

“In your response, you provided a follow-up cleaning validation report in which you only assessed the carryover of niacin swab samples but not progesterone, which was included in your initial cleaning validation,” FDA says in the letter. “The lack of progesterone (b)(4) [commercially confidential information] is concerning considering the failing residue results you provided to investigators would yield unacceptable levels of progesterone cross-contamination.”

On Friday, Lonza announced plans to construct a large-scale commercial drug product fill and finish facility in the town of Stein, Switzerland.

Lon­za to in­vest $500M+ on fill-fin­ish fa­cil­i­ty on its home turf

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

Man­u­fac­tur­ing roundup: Teru­mo BCT part­ners with Bio­Bridge sub­sidiary to man­u­fac­ture cell and gene ther­a­pies; WuXi STA opens plant for HPA­PI pro­duc­tion

As the manufacturing of cell and gene therapies is ramping up and companies are starting to invest in their manufacturing capabilities, Terumo Blood and Cell Technologies have formed a partnership to stay in the game.

According to the company, it has signed a new collaborative agreement with GenCure, a subsidiary of BioBridge Global, to extend and unify cell and gene therapy manufacturing solutions.

No­var­tis to re­sume the pro­duc­tion of two ra­di­oli­gand ther­a­pies af­ter re­solv­ing qual­i­ty is­sues

Earlier this year, Novartis touted its radioligand as a major piece to counter competition in the cancer space. However, the physical production of its products has had anything but a smooth ride.

In May, Novartis had to suspend production of Lutathera and Pluvicto, its two primary radiotherapies. According to the company, this was done out of an abundance of caution as a result of potential quality issues identified in its manufacturing. The production suspension impacts the commercial and clinical trial supply of the products.